2015 ASCO/AACR Methods in Clinical Cancer Research Workshop

Faculty Page 1 of 25

Workshop Co-Director (AACR): Patricia M. LoRusso, DO, PhD For over 24 years, I have been conducting early phase (phase I and II) clinical trials with a strong emphasis on, novel trial designs, translational concepts and novel/novel drug combinations. I have been the PI of the NCI Early Phase Trial granting mechanism for over 20 years, initially as a U01 holder (19 years) and most recently as the Principal Investigator (PI) of the UM1 ETCTN grant through CTEP. As a leader in early therapeutics, I recognize the urgent need for collaboration in development, execution, recruitment and completion of clinical trials. I recognize the need and urgency for correlative/translational studies within the context of early phase trials to better understand the mechanisms of response and/or resistance. It is also important to investigate drug:target effects directly at the tumor level and not just by surrogate endpoints, both when investigating monotherapy as well as with drug combinations. Integrating biomarkers is crucial to help better understand tumor biology for improved drug selection and therapeutic outcomes. It is important to study the pharmacokinetic, pharmacodynamic and translational components of a drug when given to humans in early clinical trials so as to better understand many of the underpinnings of a drug’s mechanism of response and/or resistance. As a co-Dream team leader for the SU2C melanoma dream team and the PI for the Genomically Enabled Metastatic Melanoma (G.E.M.M.) Protocol, I understand the importance of team participation. As co-PI of a Komen Promise grant (with Drs. Wicha and Trent), I have worked with a national team of investigators, specifically attempting to identify racial differences in triple negative breast cancer and trying to understand the disease at a stem-cell level. I have led the clinical/translational component of this grant, using my clinical trials expertise to assist in trial development and execution. Workshop Co-Director (ASCO): Jyoti D. Patel, MD Dr. Patel is Associate Professor of Medicine at the Feinberg School of Medicine of Northwestern University. She specializes in the treatment of lung cancer. She graduated from Northwestern University with a degree in English Literature and received her MD from Indiana University. She then completed residency at Northwestern University, where she also served as Chief Medical Resident. She completed medical oncology fellowship at Memorial Sloan-Kettering Cancer Center. Dr Patel now serves as the Thoracic Oncology Program Leader of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. She has authored numerous publications and has served as the principal investigator of multiple clinical trials. She is active in the Thoracic Committee of the Eastern Cooperative Oncology Group and is a member of the NCCN Non-Small Cell Lung Cancer and Small Cell Lung Cancer Panels. She has served on the Scientific Program Committees of ASCO and IASLC. She was awarded the Early Career Achievement Award from Indiana University School of Medicine. She was also part of ASCO’s prestigious Leadership Development Program. In addition to being a clinical researcher, she has been selected to be a College Mentor to one quarter of Northwestern University’s Feinberg School of Medicine class, teaching and advising the College throughout the four years of the medical school curriculum. Specialty Preferences: Lung Cancer


Workshop Co-Director (Biostatistician): Yu Shyr, PhD Yu Shyr received his Ph.D. in biostatistics from the University of Michigan (Ann Arbor) in 1994 and subsequently joined the faculty at Vanderbilt University School of Medicine. Dr. Shyr is a Fellow of the American Statistical Association and FDA committee voting member. He has delivered more than 200 abstracts at professional meetings worldwide and published more than 400 peer-reviewed papers in a variety of journals (h-index = 83). He is a member of the US National Academy of Medicine (IOM) Committee on Policy Issues in the Clinical Development of Biomarkers for Molecularly Targeted Therapies. He has served as a member of the US National Cancer Institute (NCI) Developmental Therapeutics Study Section, Cancer Immunopathology and Immunotherapy Study Section and the Population and Patient-oriented Training Study Section; he also has served on numerous NIH/NCI SPORE, P01, and CCSG review panels/committees, as well as the epidemiology section of the U.S. Army Medical Research and Material Command Breast Cancer Research Program (BCRP). He currently serves on 14 external advisory boards and directs the biostatistics and bioinformatics cores for the NCI-funded Vanderbilt University Breast Cancer SPORE, GI Cancer SPORE, and other program projects. In addition, Dr. Shyr is the principle investigator of the NCI U01 grant of Barrett’s esophagus translational research network coordinating center (BETRNetCC). He is the associate editor for JAMA Oncology. Dr. Shyr’s current research interests focus on developing statistical bioinformatic methods for analyzing next-generation sequencing data including a series of papers on estimating the sample size requirements for studies conducting DNA and RNA sequencing analysis. Dr. Shyr has been a faculty member of the AACR/ASCO Methods in Clinical Cancer Research Vail Workshop since 2004. Specialty Preferences: biostatistics; bioinformatics; trial design Alex A. Adjei, MD, PhD, FACP Alex A. Adjei is Consultant in Medical Oncology at Mayo Clinic and Professor of Oncology in the Mayo College of Medicine. Dr Adjei is Director of the Early Cancer Therapeutics Program across all three Mayo Clinic sites, and is also director of Global Oncology. He is the Principal Investigator of the Mayo Phase I and Phase II NCI grants. Dr Adjei has served on a number of National Cancer Institute Committees. He was Vice-Chair of the North Central Cancer Treatment Group and Lung Cancer Committee Chair. He is currently co-chair of the Thoracic Malignancies Steering Committee, and is a member of Subcomittee A (reviewing cancer centers) of the National Cancer Institute. He is the Editor-in-Chief of the Journal of Thoracic Oncology. Dr Adjei’s research is focused on experimental therapeutics and clinical drug development. He received the first ASCO Drug Development Research Professorship 2012-2017, in recognition of his mentorship and his work in cancer drug development. He has authored 240 publications dealing primarily with preclinical pharmacology and phase I trials as well as novel therapeutics/phase II trials of lung cancer.


Specialty Preferences: Preclinical therapeutics, Phase I clinical trials, Clinical Pharmacology, Biomarkers Pharmacogenomics, Lung Cancer, Health Disparities Vikram S. Bajaj, MD, PhD I work at Verily Life Sciences (Google/Alphabet). I am also an Associate Professor of Radiology (consulting) at Stanford University, an affiliate scientist of the University of California, Berkeley and the Lawrence Berkeley National Laboratory, and a former affiliate of the Wuhan Institute of Physics and Mathematics (Chinese Academy of Sciences). The content on this site is purely personal, however. Specialty Preferences: molecular imaging and nanotechnology for the early detection of disease, experimental and computational systems biology: high density “-omics” methods, optically-detected NMR and MRI, nanoscale NMR and MRI, microfluidic NMR for applications including point of care analysis, dynamic nuclear polarization and associated millimeter-wave devices for sensitivity-enhanced NMR and MRI, structural biology methods for the elucidation of membrane protein and amyloid structures. Thomas M. Braun, PhD Dr. Thomas M. Braun is a Professor at the University of Michigan (UM) School of Public Health and has been a faculty member of the Biostatistics Department since 1999. He has a broad background in the design and analysis of clinical trials and clinical data specific to oncology. He is a leading expert in the design of adaptive Phase I clinical trials and has also published methodology related to the analysis of longitudinal data, diagnostic tests, and competing risks. He has been the primary statistician for the UM Comprehensive Cancer Center (UMCCC) Blood and Marrow Transplantation Program and is a current member of the UMCCC Protocol Review Committee. He is also the Analytics Lead for the Michigan Breast Oncology Quality Initiative (MiBOQI), which seeks to implement policy strategies to improve the quality and safety of breast cancer treatment and outcomes. Specialty preferences: stem cell transplant, leukemia, lymphoma, breast cancer. Michael A. Carducci, MD Michael A. Carducci, MD, is the AEGON Professor in Prostate Cancer Research at the Johns Hopkins University School of Medicine. He is the Associate Cancer Center Director for Clinical Research within the Johns Hopkins Kimmel Cancer Center. He is the Regional Research Director for the National Capital Region for the Kimmel Cancer Center. A translational researcher, Dr. Carducci directs a small laboratory program focused on bringing small molecules into early phase clinical trials. Overall, his laboratory and clinical research focus is on the development and evaluation of new therapies for urologic cancers. Incorporation of pharmacodynamics, novel biomarkers, and targeted imaging has been key elements of many of the trials led by Dr.


Carducci. To complete these studies, Dr. Carducci facilitates and brings together a multi-disciplinary team from urologists, radiation oncologists, pathologists, biostatisticians, and medical oncologists. Other areas of interest include palliative and end of life care, survivorship, and use of patient reported outcomes in clinical research and care. A Fellow of the American College of Physicians and a Fellow of the American Society of Clinical Oncology, Dr. Carducci has received peer-reviewed funding for his laboratory and clinical research from the National Cancer Institute, Department of Defense, and the Prostate Cancer Foundation. Mentorship of students, fellows, and junior faculty has been another focus of Dr. Carducci’s career in medicine, receiving numerous teaching awards. Dr. Carducci received the Michaele Christian Award and Lectureship for Oncology Drug Development at the National Cancer Institute in 2011. He is the Chair of the Genitourinary Oncology Committee of ECOG-ACRIN, and an active member of the GU Steering Committee for the NCI. Dr. Carducci is Co-Chair of the Investigational Drug Steering Committee for the NCI. He is an Associate Editor for GU Cancers for the Journal of Clinical Oncology. A graduate of Georgetown University, Dr. Carducci received his medical degree with high distinction from Wayne State University School of Medicine. He completed an internal medicine internship, residency and chief residency at the University of Colorado Health Sciences Center. He went on to complete medical oncology and research fellowships at the Johns Hopkins Oncology Center at Johns Hopkins Hospital. Specialty Preferences: GU Cancers, Phase 1 trials, Cooperative Group trials, palliative care Edward Chu, MD Dr. Edward Chu is Professor of Medicine and Pharmacology & Chemical Biology, Chief of the Division of Hematology-Oncology, and Deputy Director of the University of Pittsburgh Cancer Institute (UPCI). He serves as Co-Leader of the UPCI Cancer Therapeutics Program, which is one of the main research programs of the cancer center, and he is Director and PI of the UPCI Phase I Program, which is one of only 12 centers in the US to be funded by the National Cancer Institute as a member of the NCI ET-CTN. Dr. Chu specializes in the treatment of colorectal and GI cancers. His clinical and translational research efforts have focused on identifying novel drugs and combination regimens for colorectal cancer and other GI cancers. In particular, he has focused on developing early-phase I/II clinical trials. He also has a strong interest in integrating Chinese herbal medicine with standard cancer chemotherapy with the goal of enhancing clinical activity and reducing the toxicity associated with chemotherapy. Dr. Chu is a member of several professional and scientific associations including American Society of Clinical Oncology, European Society of Medical Oncology, American Association for Cancer Research, American Association for the Advancement of Science, and American College of Physicians. He also serves on the scientific advisory boards of several NCI-designated cancer centers, including Albert Einstein, Dartmouth, Columbia, University of Southern California, Medical University of South Carolina, and University of Vermont, and serves on the advisory board for the Taiwan National Cancer Institute.


Ralph B. D'Agostino Jr., PhD Dr. D'Agostino holds a Ph.D. in Mathematical Statistics from Harvard University. He is a Fellow of the American Statistical Association and a Professor of Biostatistical Sciences at the Wake Forest School of Medicine (WFSM). He joined WFSM in 1994, and in 2004 became the Director of the Biostatistics Core of the Comprehensive Cancer Center (CCC). During his time at WFSM he has served as the PI for several large scale (RO1) grants and contracts with the NIH/CDC. He has also published more than 275 manuscripts and book chapters in areas of statistical methodology, cardiovascular disease, diabetes, cancer and genetics. He has served on numerous NIH study sections as a permanent or ad hoc member and currently sits on several Data Safety Monitoring boards for clinical trials, many for cancer related protocols. At WFSM he has collaborated with numerous investigators on the design and analysis of cancer clinical protocols/trials and is the chair of the Clinical Research Oversight Committee for the CCC at WFSM. His statistical research areas include methods for handling missing data as well as analytical techniques for observational (non-randomized) research, including methods using propensity scores. He looks forward to the opportunity to collaborate with the other faculty and students during the Vail Workshop. He enjoys spending time with his wife and children, gardening, playing Frisbee golf, hiking and playing games such as chess, Settlers of Catan, Dominion, or Ticket to Ride. Mary L. (Nora) Disis, MD Mary L. (Nora) Disis, M.D., is the Athena Distinguished Professor of Breast Cancer Research, Associate Dean for Translational Health Sciences in the University of Washington (UW) School of Medicine, Professor of Medicine and Adjunct Professor of Pathology and Obstetrics and Gynecology at UW and a Member of the Fred Hutchinson Cancer Research Center. She directs the Institute of Translational Health Science at UW as well as the Tumor Vaccine Group. Dr. Disis is an expert in immunoncology and translational research. Her research interest is in the discovery of new molecular immunologic targets in solid tumors for the development of vaccine and cellular therapy for the treatment and prevention of common malignancies. In addition, her group evaluates the use of the immune system to aid in the diagnosis of cancer and develops novel assays and approaches to quantitate and characterize human immunity. She holds several patents in the field of targeted cancer immunotherapy and immune-based diagnostics. Dr. Disis is a member of the American Society of Clinical Investigation and the Association of American Physicians. Dr. Disis holds a leadership award from the Komen for the Cure Foundation and was recently named as an American Cancer Society Clinical Professor. She is the Editor-in-Chief of JAMA Oncology. She has been a faculty member of the Vail Course for many years and is a past Program Director of the course. Specialty Areas: immunotherapy, breast cancer, ovarian cancer, biomarkers


Everett Dodson Mr. Dodson is a specialist in community outreach and patient advocacy. He has a long history of working in the District of Columbia to address the morbidity and mortality due to cancer. As a Community Health Educator at Georgetown/Lombardi Comprehensive Cancer Center, he develops and implements community-based programs aimed at cancer prevention. He is currently involved in several projects focusing on oral health disparities, biospecimen research, clinical trials, and an environmental justice project with the Georgetown University Law Center. Mr. Dodson has strong interpersonal skills that have helped him develop relationships with many community residents. He has recruited community residents to serve on the Georgetown/Lombardi Health Disparities Initiative Community Advisory Board, and has served as an advisor to the Board of Directors of the South Washington West of the River Family Collaborative in Ward 6 and was previously a member of the Ward 8 Health Council. Mr. Dodson is the former Director of the Men Take Ten Prostate Cancer Screening and Education Program at the Howard University Cancer Center where he also was a Clinical Research Associate with the clinical trials program. He also facilitated cancer prevention programs such as smoking cessation. Mr. Dodson has been recognized locally and nationally for his efforts as a community health advocate. The Prostate Net presented him with their 2007 “In The Know Award” for patient advocacy for his efforts on behalf of men’s health. Mr. Dodson has received the National Cancer Institute’s Directors Service Award for his service on the Clinical Trials and Translational Research Advisory Committee, and has served on the National Cancer Institute’s Director’s Consumer Liaison Group and Patient Advocate Steering Committee, and is a former member of the Cancer and Leukemia Group B Data Safety and Monitoring Board. He is currently a member of the National Cancer Institute’s Adult Late Phase Central Institutional Review Board, patient advocate faculty member for the ASCO/AACR Methods in Clinical Cancer Research Workshop, and a member of the Cancer Support Community National Advisory Council for the Cancer Experience Registry: Prostate Cancer. Mr. Dodson has over 20 years of community engagement and men’s health. James H. Doroshow, MD Dr. James H. Doroshow has been the Deputy Director for Clinical and Translational Research of the National Cancer Institute since 2011, and the Director of NCI’s Division of Cancer Treatment and Diagnosis since 2004. He continues to pursue his own research program as a Senior Investigator in the Developmental Therapeutics Branch of the NCI’s intramural Center for Cancer Research. He is the author of over 400 full-length publications in the areas of molecular pharmacology, the role of oxidant stress in tumor cell signal transduction, and novel therapeutic approaches to solid tumors. From 1983 to 2004, Dr. Doroshow was the Chairman of the City of Hope Comprehensive Cancer Center’s Department of Medical Oncology and Therapeutics Research, and Associate Cancer Center Director for Clinical Investigation. He has served on the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration, the Medical Oncology Board of the American Board of Internal Medicine, and as Chair of two NIH study sections: Experimental Therapeutics II and Subcommittee A, Cancer Centers. He is currently a member of both


the Forum on Drug Discovery, Development, and Translation and the National Cancer Policy Forum of the National Academy of Medicine of the National Academies of Science. He is also the Associate Editor for Oncology of the 25th Edition of the Cecil Textbook of Medicine. Dr. Doroshow received his A.B. degree from Harvard College in 1969 and graduated from Harvard Medical School in 1973. Following an Internal Medicine residency at the Massachusetts General Hospital, he completed a fellowship in Medical Oncology at the Medicine and Clinical Pharmacology Branches of the National Cancer Institute, NIH. Karyn A. Goodman, MD, MS Dr. Karyn Goodman is a board-certified radiation oncologist specializing in cancers of the gastrointestinal tract. Dr. Goodman received her undergraduate and medical degrees from Stanford University and an M.S. in Epidemiology from the Harvard School of Public Health. She completed residency training at Memorial Sloan-Kettering Cancer Center (MSKCC) and attended the Vail Workshop in 2003. She was on the faculty at Stanford University from 2004-2006, at MSKCC from 2007-2015, and is now a Professor of Radiation Oncology and Medical Director of the Cancer Clinical Trials Office at the University of Colorado. Dr. Goodman is an internationally recognized expert in gastrointestinal cancers and has served in numerous leadership roles on ASTRO, ASCO, and NRG committees as well as multiple national committees evaluating best practices and quality of care in radiation oncology. She serves as the national Radiation Oncology principal investigator of the RTOG/NRG 0848 study, a phase III trial evaluating the use of post-operative radiotherapy for pancreatic cancer. She is the national Study Chair for the Alliance Cooperative Group phase II trial (CALGB 80803) investigating PET scan-directed therapy for esophageal cancer. She developed several investigator-initiated trials evaluating the use of new radiotherapy techniques for gastrointestinal tumors and holds two patents for the development of brachytherapy applicators. She received and ASCO Young Investigator Award as well as multiple grants to support her research in radiation oncology. She has published over 100 peer-reviewed articles, review articles, and chapters. Specialty Areas: Stereotactic Body Radiotherapy (SBRT) for pancreas and liver malignancies, Evaluating patient-reported outcomes and quality of life during and after RT, Combining immunotherapy with SBRT for GI cancers, Imaging as a biomarker for treatment response, Motion management during focal delivery of RT Lyndsay N. Harris, MD Lyndsay Harris is an internationally recognized expert on breast cancer research and treatment where she has focused on translating findings from the laboratory to the clinic. She has worked in the field of biomarkers of breast cancer for over 25 years and has studied mechanisms of resistance to both chemo- and targeted therapy. She has published over 130 papers, chapters and reviews and participated in grant reviews through the Department of Defense, Komen and NIH. More recently her work has applied genomic technologies to understand resistance to treatment in vivo using tissue biopsies from clinical trials. She is the Program Director for Breast Cancer in the Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute.


Roy S. Herbst, MD, PhD Dr. Roy S. Herbst is the Ensign Professor of Medicine, Professor of Pharmacology, Chief of Medical Oncology, Director of the Thoracic Oncology Research Program, and Associate Director for Translational Research at the Yale Cancer Center (YCC) and Yale School of Medicine in New Haven, Connecticut. Prior to his appointment at Yale, Dr. Herbst was the Barnhart Distinguished Professor and Chief of the Section of Thoracic Medical Oncology in the Department of Thoracic/Head and Neck Medical Oncology, at The University of Texas M.D. Anderson Cancer Center (UT-MDACC) in Houston, Texas. He also served as Professor in the Department of Cancer Biology and Co-Director of the Phase I Clinical Trials Program. Dr. Herbst’s primary mission is the enhanced integration of clinical, laboratory, and research programs to bring new treatments to cancer patients. He has led the Phase I development of several of the new generation of targeted agents for non-small cell lung cancer (NSCLC), including gefitinib, erlotinib, cetuximab, and bevacizumab. More recently, he participated in the successful registration of pembrolizumab for the treatment of advanced non-small cell lung cancer, following the successful Yale-led KEYNOTE 10 study of the immune therapy drug commonly used to treat other cancers. He was co-leader for the BATTLE-1 clinical trial program, co-leads the subsequent BATTLE-2 clinical trial program, and served as a Co-program Leader of the Developmental Therapeutics Program for the YCC Support Grant. Dr. Herbst’s laboratory work is focused on immunotherapy angiogenesis; dual epidermal growth factor receptor (EGFR)/vascular endothelial growth factor receptor (VEGFR) inhibition in NSCLC, and targeting KRAS-activated pathways. More recently, he has explored predictive biomarkers for the use of immunotherapy agents. This work has been translated from the preclinical to clinical setting in multiple Phase II and III studies which he has led. Dr. Herbst was a member of the National Cancer Policy Forum (1998-2014) for which he organized an Institute of Medicine meeting focused on policy issues in personalized medicine. He is a member of ASCO and, as a member of AACR, he chairs the Tobacco Task Force. He is a fellow of the American College of Physicians and an elected member of the Association of American Physicians. Dr. Herbst is also a member of the medical advisory committee for the Lung Cancer Research Foundation and chair of the communications committee for ASCO and the International Association for the Study of Lung Cancer. He is currently the Vice Chair for Developmental Therapeutics for the Southwestern Oncology Group (SWOG) Lung Committee, Principal Investigator of the SWOG 0819 trial, and steering committee chair for the Lung Master Protocol (Lung MAP). Dr. Herbst was awarded the 2010 Waun Ki Hong Award for Excellence in Team Science by the Division of Cancer Medicine, UT-MDACC. The Alvin S. Slotnick Lecture Award for notable contributions to lung cancer research was bestowed upon him by Dana-Farber/Brigham and Women’s Cancer Center in 2014. That same year, the Bonnie Addario Foundation honored him with the Annual Addario Lectureship Award and the Bonnie J. Addario Excellence in Collaboration and Innovation Award. In 2015, the Clinical Research Forum presented his project “Predictive Correlates of Response to the Anti-PD-L1 Antibody MPDL3280A in Cancer Patients” its top Clinical Research Achievement Award in the United States for 2015. His work has been funded by ASCO, AACR, the United States Department of Defense, and the National Cancer Institute. In 2015, his team at Yale was awarded a lung cancer SPORE by the NCI, and he serves as a principal investigator for the AACR/ Stand Up to Cancer Dream Team grant.


S. Percy Ivy, MD S. Percy Ivy, MD is the Associate Chief (2005) of the Investigational Drug Branch (IDB) which is part of the Cancer Therapy Evaluation Program (CTEP) in the Division of Cancer Treatment and Diagnosis of the National Cancer Institute. She received her medical and subspecialty training at Tulane University Medical School, Vanderbilt University Medical Center and the National Cancer Institute, respectively. During her fellowship she worked in the Molecular Pharmacology Section which focused on the molecular mechanisms of drug resistance mediated by the ABC transporter genes in models of breast cancer and carcinogenesis. She is currently an Associate Professor of Pediatrics at the George Washington University School of Medicine on the faculty at Children’s National Medical Center where she attends in the leukemia clinic. In her role as Associate Chief of IDB she supervises several Senior Investigators in the Experimental Therapeutics Section I with a focus on angiogenesis inhibitors, heat shock protein 90 inhibitors and inhibitors of receptor:ligand interactions including disregulated cancer stem cell embryonic signaling pathways for hedgehog, notch, wnt and others. She has received 13 NIH Merit Awards for her work on specialized studies in patients with hepatic and renal dysfunction using cancer investigational therapeutics, use of novel imaging techniques for the evaluation of investigational agents in early clinical trials and most recently for assisting the in the implementation of the Investigational Drug Steering Committee (IDSC) which is part of the Clinical Trials Working Group, an NCI initiative for improving NCI-sponsored clinical trials in the US. She serves on the IDSC coordination team as well as starting the angiogenesis task force and now chairing the Clinical Trial Design Task Force for Early Clinical Trials and is the Program Director for the Experimental Therapeutics Clinical Trials Network. She serves on the Scientific Committee for the AACR-NCI-EORTC Molecular Targets Conference and for the Experimental Therapeutics Section for ASCO. She has presented both nationally and internationally on topics related to early therapeutics development, biomarker development, the role of anti-angiogenic agents in cancer therapy, clinical trials for patients with hepatic and renal dysfunction and on the experimental therapeutics program in CTEP. She has published 145 manuscripts and 7 book chapters in her areas of interest in experimental therapeutics. She has received the Margaret B. and Cyril A. Shulman Distinguished Service Award for starting the general pediatric clinic for medically indigent children at Bread for the City/Zaccheus Free Clinic and supports Doorways for women and children who are victims of abuse. Roy B. Jones, MD, PhD Dr. Roy Jones is Professor of Medicine in the Department of Blood and Marrow Transplantation, MD Anderson Cancer Center. He received undergraduate and MD degrees from Duke University and a PhD in medicinal chemistry from Emory University. Prior to coming to MD Anderson in 2002, he was director of informatics for the University of Colorado Cancer Center, Professor of Medicine, University of Colorado Health Sciences Center, and director of the Bone Marrow Transplant Program. Dr. Jones has served as a reviewer on several NCI Study Sections including Subcommittee D (Clinical Program Project Grants) and CONC (Clinical Oncology Study Section).


Dr. Jones is board certified in Internal Medicine and Medical Oncology. His clinical research interests are the pharmacology of high-dose chemotherapy,the developmental therapeutics of hematopoietic stem cell transplantation, and computerized approaches to the design, approval, and management of clinical trials. He is the author of more than 150 book chapters and original articles in the areas of pharmacology of intensive chemotherapy and hematopoietic stem cell transplantation (HSCT). His clinical interests include the treatment of a variety of cancers with HSCT. Kay Kays I am a 20 year pancreatic cancer survivor….having survived initial dx, locally advanced, and 2 metasteses. My journey involved becoming patient active with my cancer at the Wellness Community-Az, initiating my research patient advocacy as a host of the 1st pancreatic cancer network in Az. I saw the need for an educational bridge between patients <-> research…and began seeking training and resources. Serving as a patient advocate with the SPORE in GI Cancer at the AZ Cancer Center was a first step in beginning to participate locally and nationally as a GI patient research advocate. My participations have included SPORE Patient Advocate Research Team (PART), Alliance for Oncolgy Clinical Trials (formerly CALGB), Gateway for Cancer Research Scientific Counselors Patient Research Advocate, Research Advocacy Network/Tissue Think Tank, Wellness Community Board of Directors, Translational Genomics Research Institute/PCRT, Department of Defense-Pancreatic Cancer, National Institute of Health Patient Centered Outcome Research Institute, and the Pancreatic Cancer Action Network Clinical trials and tissue donation are my main interests in helping cancer research move successfully forward for patients. I initiated and served as the Deputy Director with AzMN in a grassroots 1 yr. grant (Tissue Donor Awareness Project or TDAP) to educate patients about “What is tissue” and “Why tissue is important for cancer reseach.” My dissemination of cancer research to patients is always a 2-Way street of learning and I am able to represent cancer patients at the grant review table with up to date information for accrual and quality of life from the real world of cancer. Susan Krivacic, MPAff Ms. Krivacic is a 27 year cancer survivor, and brings a wealth of personal and professional experience to her role as an independent patient advocate to local and national cancer organizations. Ms. Krivacic has been a co-facilitator and member of Cancer Anonymous (CA) in Austin, Texas since 1989 (now known as Friends of Cancer Anonymous). In 1990, she founded a local young adult cancer support group. She continues her local support work with cancer patients by helping them navigate the world of cancer treatments and survivorship, accompanying many of them to their initial oncology visits. Ms. Krivacic currently divides her time between patient advocacy and running her own consulting company- PBG Consulting, LLC, a strategic management consulting firm. Ms. Krivacic is a current patient advisor to and member of the national organization: Patient’s Against Lymphoma (PAL). She is a current scientific board member serving on a Commercial Central Independent Review Boards (IRB) located in Austin, Texas and has been a past member of another Board. Also, she currently serves as a member of the NCI-Adult Early Phase CIRB (National Cancer


Institute’s Central IRB). Additionally, she served as a Member of the US Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2011-2014. As a patient advocate, she frequently presents and consults on advocacy and survivorship issues, on cancer clinical research and drug development, and also serves on a number of oncology advisory boards. Ms. Krivacic’s advocacy efforts formed her work as a Patient Representative to the Oncology Drug Advisory Committee (ODAC) beginning in 1998 and Consultant for the FDA’s Cancer Drug Development Program enabling her to represent the patient perspective on a number of advisory committees at the FDA, including committees with other disease indications. She has received several awards for her work as an Advocate, including the FDA Commissioner’s Special Citation Award in 2004 for the Development of a Guide for Patient Representatives Serving on FDA Advisory Committees. Over the years, Ms. Krivacic has addressed many cancer patients\survivors, clinical researchers, and scientists across the country at meetings, panels, workshops, and conferences. Ms. Krivacic served on the faculty of Accelerating Anticancer Agent Development and Validation Workshop in 2009 and 2015, National Comprehensive Cancer Network’s (NCCN) 2010 Advocacy Training Day Panel, and NCCN’s 2012 Data Needs Work Group Panel. She currently serves on NCCN’s NHL Treatment Guidelines Panel. Ms. Krivacic’s former professional career included leadership roles within the contract clinical research and life sciences industries. She has published several articles and reports on clinical trials. Ms. Krivacic received her Bachelor of Arts degree from the University of Texas, Austin, Texas in 1981, and a Master of Public Affairs, with a concentration in Health Policy, from Lyndon Baines Johnson School of Public Affairs at the University of Texas, Austin, in 1982. She received the J. Lassen Boysen Scholar Academic Year 1980 and was a Fulbright Scholar at the University of Zagreb, Yugoslavia, in 1984. Brenda F. Kurland, PhD Brenda F. Kurland, Ph.D., is a Research Associate Professor in the Department of Biostatistics at the University of Pittsburgh. She received her Ph.D. in biostatistics from the University of Washington, developing methods for longitudinal data analysis with applications to gerontology and geriatrics. She is a member of the Journal of Clinical Oncology editorial board, and a member of the American Statistical Association (past president of the Puget Sound chapter), the International Biometric Society (program chair for the 2010 WNAR annual meeting), the Society for Clinical Trials, and the American Association for Cancer Research. Her current area of emphasis is the design and analysis of cancer clinical trials, especially those involving quantitative imaging. Her methodologic interests and clinical collaborations have led to independent research analyzing correlated data from multiple lesions in PET images, and evaluating effects of injection-to-acquisition uptake time variations in PET data. This is her fifth year on the Vail Workshop faculty. Daniel A. Laheru, MD In 1990, Dr. Daniel A. Laheru graduated magna cum laude in chemistry from the University of Utah. From 1992-93 he was a Stanley Sarnoff Society of Cardiovascular Fellow and was awarded a Howard Hughes Medical Institute Research Training Fellowship for Medical Students in the laboratory of Bernardo Nadal-Ginard, MD, PhD at the Children’s Hospital in Boston, MA. He then received his medical degree from The Baylor College of Medicine in 1995. Dr. Laheru completed his Internal


Medicine residency at the University of Utah Hospital and Clinics where he was named Co-outstanding senior resident, and subsequently completed a Medical Oncology Fellowship at the Johns Hopkins University School of Medicine. In 2001, he joined the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins where he is an Associate Professor in Medical Oncology and Clinical Director of the Gastrointestinal Oncology Division. In April 2010, Dr. Laheru was installed as the inaugural Ian T. MacMillan Professor ship in Clinical Pancreatic Cancer Research. Dr. Laheru is the codirector of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care. Dr. Laheru’s clinical research interests are in developing and testing new therapies for the treatment of pancreatic cancer. In collaboration with Elizabeth Jaffee MD, Lei Zheng MD PhD and Dung Le, MD, he has initiated clinical studies to optimize a vaccine approach using GM-CSF transfected pancreatic cell lines as vaccine in patients with resected and metastatic pancreas cancer. Dr. Laheru has incorporated correlative biologic and immunologic studies that should provide important information to better understand optimal vaccine boosting schedules as well as to identify antigens that can be predictive in-vitro markers for anti-tumor immune responses. Data generated from this work will serve as the foundation for the development of novel new antigen specific vaccines for pancreatic cancer. Dr. Laheru’s work in pancreatic cancer vaccines has been funded by a National Institutes of Health K23 Mentored Patient-Oriented Research Career Development Award. In collaboration with Christine Iacobuzio-Donahue, Dr. Laheru is investigating mechanisms of chemotherapy resistance in pancreatic cancer. Data generated from this work should allow clinicians to predict in advance which patients would be expected to benefit from a particular chemotherapy drug. In collaboration with Anirban Maitra MD and Ana de Jesus MD. Dr. Laheru is developing and testing new targets for therapy in patients with metastatic pancreas cancer involving pancreatic cancer growth pathways that were identified by Johns Hopkins scientists. Some of the awards for Dr. Laheru include the 2000 AACR Bristol Myers Squibb Oncology Fellowship in Clinical Research and a 2000 American Society of Clinical Oncology (ASCO) Young Investigator Award. He serves as a faculty member for the AACR/ASCO Workshop on Methods in Clinical Cancer Research and serves on a number of National review grants committees including the Conquer Cancer Foundation, Scientific Review Committee for the Pancreatic Cancer Action Network/AACR Innovative research grants. Specialty Preferences: Gastrointestinal oncology; specifically pancreatic and colon cancer Barbara K. LeStage, MHP Barbara K. LeStage, MHP is a 21-year breast cancer survivor and an advocate of more than 30 years. She served as chair of the American Cancer Society Executive Committee and Board of Directors in the Massachusetts Division and was a member of the ACS National Board of Directors from 1988-1999. She served on three ACS national extramural research committees and the Council for Extramural Grants. She is past chair of NCI's Director's Consumer Liaison Group and past member of NCI's Central IRB, Advisory Committee to the Director, Informed Consent Template Update Working Group and Concise Informed Consent Document Planning Committee. She is currently serving on NCI’s Clinical Imaging and Patient Advocate Steering Committees, the Clinical Trials Transformation Initiative’s Steering Committee and Trial Recruitment Team and Dana/Farber/Harvard Cancer Center’s the Breast Cancer Advocate Group where she both participates in peer review panels for DF grants and works with DF researchers to prepare applications for outside research organizations. Barbara chaired the Patient Advocacy Committee of the American College of Radiology Imaging Network (ACRIN) for seven years. She was also a member of ACRIN's Steering Committee and protocol teams for two trials. She was a faculty member of the 2006 Clinical Trials Methodology Workshop conducted by the Radiological Society of North America. Barbara received a B.S. degree from Denison University and


a Master of Health Professions Degree from Northeastern University’s Bouve College of Pharmacy and Health Sciences. She is a graduate of the National Breast Cancer Coalition’s Project LEAD and the American Cancer Society’s Stakeholder Training. She twice attended the American Association for Cancer Research’s Scientist-Survivor program. This is her sixth year as a member of the Vail Workshop faculty. Speciality Areas: breast cancer, informed consent and trial accrual. Stuart M. Lichtman, MD, FACP I am a medical oncologist and member of the Gynecologic Oncology Disease Management Team at Memorial Sloan Kettering Cancer Center and participate in the 65+ Clinical Geriatrics Program. I primarily treat gynecologic cancers but also see solid-tumor patients with melanoma and sarcoma. My main research interest is in the treatment and evaluation of older cancer patients. I am involved in a number of research organizations including the Elderly Taskforce of the Gynecologic Oncology Group/NRG, the Cancer in the Elderly committee of the Alliance for Clinical Trials in Oncology, the Cancer and Aging Research Group and member of the Gynecologic Cancer Steering Committee of the NCI. I have been on the Board of Directors and served as Treasurer of the International Society of Geriatric Oncology (SIOG) since 2010 and have participated in multiple taskforces (Chemotherapy, Geriatric Assessment, Renal Dysfunction, Lymphoma, and Oral Chemotherapy) and as the US National Representative and Scientific Chair of the 2011 annual meeting. I also serve on the editorial board of the Journal of Geriatric Oncology, prior member of the External Advisory Board of the University of Iowa Cancer Center, Governing Board Cancer, and the Kidney International Network. As a member of the American Society of Clinical Oncology (ASCO), I have been on the Clinical Practice Committee and Scientific Program Committee and currently the Geriatric Oncology Special Interest Group, Associate Editor for Geriatric Oncology of the ASCO Post and Chair of the Organ Dysfunction Working Group of the ASCO Eligibility Criteria Project. I have been a guest editor for the Journal of Clinical Oncology on a special edition devoted to geriatric oncology in 2007 and 2014. In 2014, I received the ASCO BJ Kennedy Award for Scientific Excellence in Geriatric Oncology and am the President-Elect of SIOG. Wendy B. London, PhD Dr. London is an Associate Professor of Pediatrics, Harvard Medical School, and the Director of Biostatistics and the Director of the Clinical and Translational Investigation Program (CTIP) in the Division of Pediatric Hematology/Oncology at Dana-Farber Cancer Institute and Boston Children’s Hospital. She is the Director of the Survey and Data Management Core of the Dana-Farber/ Harvard Cancer Center. She has 18 years of experience in the design, conduct, analysis, and reporting of clinical trials and biological studies in pediatric cancer. She serves as a member of the Children’s Oncology Group (COG) Neuroblastoma Steering Committee, and held the position of Lead Statistician for the COG Neuroblastoma Committee for 16 years. Her contributions include a phase 3 trial that demonstrated superior outcome of treatment including the chimeric 14.18 antibody (resulting in FDA approval of dinutuximab), as well as a phase 3 trial that


demonstrated superiority of two autologous stem cell transplants (SCT); both trials were in high-risk neuroblastoma (NB) patients post-SCT. Another phase 3 trial for which she was the statistician supported a reduction of therapy for intermediate risk NB patients. Dr. London was instrumental in developing the COG Neuroblastoma Committee’s Virtual Tumor Bank (VTB) of specimen, biology, and outcome data for all COG patients with neuroblastoma, and developed the automated systems for performing treatment intensity (risk group) assignment. Dr. London has served as a permanent member of the NIH/NCI Clinical Oncology Study Section (2006-10), and on Subcommittee H in review of the cooperative groups. She is a member of the program committee for the American Society of Clinical Oncology (ASCO) annual meeting, a member of the editorial board of the Journal of Clinical Oncology, and a faculty member of the ASCO/American Association for Cancer Research (AACR) Methods in Clinical Research Workshop in Vail, CO. Internationally, Dr. London serves as the Chair of the Statistics Committee on the International Neuroblastoma Risk Groups (INRG) task force, where she collaborated in the development of a global system for pre-treatment risk stratification. Michael T. Lotze, MD Michael T. Lotze, MD, is Professor of Surgery, Immunology, and Bioengineering; Vice Chair of Research within the Department of Surgery; Asst. Vice Chancellor in the six schools of the Health Sciences at Pitt; and Co-Director of Cytometry within the University of Pittsburgh Cancer Institute as well as Director of the UPCI International Academy. His research work includes modern immunotherapy and gene therapy, dendritic cell and cytokine therapies, and investigation of the role of mitochondria, metabolism, and unscheduled cell death in cancer. Dr. Lotze has worked in the field of immunology and clinical medicine for over 30 years and has had the opportunity to personally review and advance the work of individuals proposing to develop translational research, particularly within cancer. Dr. Lotze is a clinician scientist who has spent the last decade assembling a team to work on the extraordinary problem of pancreatic cancer. With Herbert J. Zeh, MD, a premier pancreatic surgeon and scientist and Daolin Tang, MD, PhD, a creative and energetic molecular biologist, he created the Center for Damage Associated Molecular Pattern Molecule (DAMP) Biology within the University of Pittsburgh Cancer Institute. Dr. Lotze worked with Dr. Natasa Miskov-Zivanov while she was at University of Pittsburgh on an NSF-funded pancreatic cancer modeling project, led by Dr. Edmund Clark, a Turing Award winner, where he introduced the team to the critical role of cancer cell death, autophagy, and DAMPs. He has partnered with Dr. Miskov-Zivanov and others at CMU for the DARPA Big Mechanism project to develop strategies to identify the ‘unknown unknowns’ in the cancer literature and to predict, identify, and test novel targets in cancer. Dr. Lotze is the co-inventor of 10 patents in dendritic cell vaccines and antigen discovery and serves as associate editor of the Journal of Immunotherapy. He is also an award-winning NCI-trained scientist (1978-1990), the inaugural Director of Surgical Oncology at Pitt (1990-2000), former Vice President of Research at GlaxoSmithKline (2001), and innovative educator who developed the UPCI International Academy (2009-2014), and a prolific scientist/tumor immunologist with over 500 publications and several books.


Stuart G. Lutzker, MD Stuart Lutzker is the Vice President of Oncology Early Clinical Development at Genentech and oversees the early phase (Phase I-II) clinical development of Genentech's oncology pipeline molecules. He joined Genentech in 2004 and assumed leadership of the Oncology Early Clinical Development Group in 2008. He has represented Genentech on a number of outside panels evaluating oncology drug development including Friends of Cancer Research and Institute of Medicine and is a member of the NCI Clinical Trial Design Task Force. Dr. Lutzker earned his BA from Columbia University and his MD-PhD (Biochemistry) from Columbia University College of Physicians and Surgeons. He completed his Internal Medicine and Medical Oncology training at Yale-New Haven Hospital and then pursued a Research Fellowship in the Department of Molecular Biology at Princeton University. Dr. Lutzker was previously on the clinical faculty of the NCI-Designated Cancer Institute of New Jersey with a dual appointment in the Department of Biochemistry at the UMDNJ-Robert Wood Johnson Medical School (recently renamed as the Rutgers New Jersey Medical School). Neal J. Meropol, MD Neal J. Meropol, MD is a medical oncologist and clinical researcher. He is the Lester E. Coleman, Jr. Professor of Cancer Research and Therapeutics, and Chief of the Division of Hematology and Oncology at University Hospitals Case Medical Center and Case Western Reserve University. He also serves as Associate Director for Clinical Research at the Case Comprehensive Cancer Center, and Associate Director for Clinical Programs and Clinical Research at the University Hospitals Seidman Cancer Center. Dr. Meropol received his undergraduate degree from Princeton University in Philosophy, and MD from Vanderbilt University. He was a resident in Internal Medicine at Case Western Reserve University, and completed hematology and oncology fellowships at the University of Pennsylvania. He spent a sabbatical at the Leonard Davis Institute of Health Economics at the Wharton School of the University of Pennsylvania. Dr. Meropol has a national reputation for his research contributions in gastrointestinal malignancies and health services research, including evaluation of new agents, predictors of response and outcome, and assessment of the economic impact of care. He currently serves as co-Chair of the National Cancer Institute Gastrointestinal Cancer Steering Committee, which oversees the development of clinical trials in the publicly-funded clinical trials system. Dr. Meropol is currently serving a 4-year term as an elected member of the American Society of Clinical Oncology (ASCO) Board of Directors. He previously served as chair of the ASCO Cancer Research Committee, and co-edited the organization’s vision statement for the future of cancer care, entitled: “Accelerating progress against cancer: ASCO’s blueprint for transforming clinical and translational cancer research.” Dr. Meropol is former co-chair of the annual Methods in Cancer Clinical Research Workshop for training the next generation of clinical researchers, co-sponsored by the American Association for Cancer Research and American Society of Clinical Oncology.


Dr. Meropol is also well-recognized for his research on patient decision making and doctor-patient communication, in particular with regard to clinical trials. He has extensively characterized the unique decision making calculus of cancer patients, and the drivers and barriers to clinical trial participation. He has developed a web-based educational program for cancer patients to improve knowledge and attitudes about clinical trials, now widely available at www.cancer.net/PREACT. Pamela R. Moffitt I am a 12+ yr survivor of Stage IV NSCLC Squamous cell. Treatment was 3 rounds of Carbo-Taxol, lung resection with removable of upper left lobe and a wedge section to lower left lobe, 33 rounds of radiation in conjunction with 3 more rounds of Carbo-Taxol. Last treatment was May 2004. I am also a 4+ yr survivor of Stage 1 NSCLC Adenocarcinoma, treatment was VATS to upper right lobe. In Oct. 2014 a CT discovered a nodule in middle right lobe PET showed no uptake, CTs in Dec. 2014, May 2015, Oct. 2015 and April 2016 have shown no growth. A Watch & Wait is in effect. Hoping this is one of those nodules that disappears or just is benign. I have been active in advocacy since 2004. Became active nationally in 2006 when I became a member of NCCTG a Cancer Cooperative Group and they immediately sent me to the Scientific Leadership Conference. My passion is review of concepts, informed consents, protocols, educational material and am now starting on study summaries. I have recently been accepted by BMJ to do reviews of manuscripts. It is imperative that the patient voice be heard starting with concepts. Researchers often only look at the science when working on their concepts and do not look at the human aspect i.e. how much are we willing to endure in the name of science (or as some say, an experiment). Many advocates are here to make sure that the human voice of reason is added to those concepts. Accrual rates are low and is of concern to the NCI cooperative group I belong to, Alliance for Clinical Trials in Oncology, Alliance for short. Perhaps lending our voices at this junction will help lead to higher accruals in the future. We became Great Grandparents as of July 10, 2015. Our great granddaughter (Jovi June) was born on her grandma Tami’s (our daughter’s) birthday. Awesome gift!! She’ll soon be a year old, where did that time go? My husband and I winter in the south as Midwest winters are cold and snowy and we prefer the sun and warmth. This past December we celebrated our 50th anniversary by having a reaffirmation of our wedding vows on the actual date of our anniversary. We have two daughters, one son-in-law, three granddaughters, two grandsons, one grandson-in-law and of course our great granddaughter. We have an English Bull dog (Gomer) who travels everywhere with us and a Calico cat (Patches) who has discovered traveling.


Motomi (Tomi) Mori, PhD, MBA Motomi (Tomi) Mori, PhD, MBA, is a Professor of Biostatistics, Oregon Health & Science University (OHSU) and Portland State University (PSU) Joint School of Public Health, and Department of Medical Informatics and Clinical Epidemiology, School of Medicine, OHSU. Dr. Mori is Walter & Clora Brownfield Endowed Professor of Cancer Biostatistics and Director of the Biostatistics Shared Resource of the Knight Cancer Institute at OHSU. After receiving her PhD in Biostatistics from the University of Iowa in 1989, Dr. Mori joined the Fred Hutchinson Cancer Research Center as an Assistant Member and as a Research Assistant Professor in the Department of Biostatistics at the University of Washington. She was recruited as a lead biostatistician for the Huntsman Cancer Institute (HCI) at the University of Utah in 1991. During her time at the HCI, she developed a research collaboration with the National Marrow Donors Program (NMDP) to estimate an optimum racial composition and size of the marrow donor registry for enhanced access to human leukocyte antigen (HLA)-matched donors among minority patients in the United States (R01HL56368 Implications of HLA Polymorphism for Donor Recruitment). Dr. Mori was recruited to direct the Biostatistics Shared Resource of the Oregon Cancer Center (now the Knight Cancer Institute) in 1999 and was also the Head of the Division of Biostatistics from 2004-2014. Her professional services activities include: NCI Subcommittee A (Cancer Centers of the National Cancer Institute Initial Review Group); External Advisory Board, Einstein & Montefiore Institute for Clinical and Translational Research; Editorial Boards for the Clinical & Translational Science and Open Access Bioinformatics. She is a successful biostatistician collaborator with over 120 publications and 27 years of experience in cancer research. Her current research interest includes clinical trial designs for molecularly targeted agents, biomarker validation and evaluation of personalized medicine in treatment and prevention settings. Specialty Preferences: early phase clinical trial designs (phase I and II), biomarker discovery, and molecular correlative studies. Daniel P. Normolle, PhD I am an Associate Professor of Biostatistics and Director of the Biostatistics Shared Resource Facility of the University of Pittsburgh Cancer Institute. I have been involved in cancer research since 1994, participating in programs in the treatment of lung, head and neck, gastrointestinal, blood and brain cancers, and in chemoprevention. My current interests are in translational research, early phase clinical trials and biomarker-adaptive trials. I annually teach the graduate course in clinical trial design in the Department of Biostatistics of the Graduate School of Public Health. Specialty Preferences: phase 1 trials; translational research design; adaptive trials; Bayesian design and analysis.


Katherine S. Panageas, DrPH Katherine S. Panageas, Dr.P.H., is Associate Attending Biostatistician, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center (MSKCC), NY, NY. She received her doctorate in biostatistics at Columbia University. Her research interests are principally in the analysis of cluster correlated data, primarily in the context of volume-outcome studies. She is currently involved in the assessment of appropriate endpoints for trials involving brain tumor patients and is evaluating the effects of interval censored data in phase II and III clinical trials with progression-free survival as a primary endpoint. Dr. Panageas works with the Clinical Immunology, Melanoma, and Neurology Services to design and analyze prospective and retrospective studies to evaluate treatment strategies including immunotherapies, explore various biomarkers, develop prediction models and develop models to estimate the risk of developing distant metastasis or local recurrences. Dr Panageas is serving her fifth year on the Vail Workshop faculty. Specialty Preferences: Clinical trial design, melanoma; immunotherapy; neuro-oncology David F. Penson, MD, MPH David F. Penson, MD, MPH is Hamilton and Howd Chair of Urologic Oncology, Chair of the Department of Urologic Surgery, Professor of Urologic Surgery, Medicine and Health Policy, and Director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. He obtained his MD from Boston University, completed his urology residency at UCLA Medical Center in Los Angeles, and then completed the Robert Wood Johnson Clinical Scholar fellowship at Yale University, while obtaining his MPH degree. He currently maintains a clinical practice in urologic oncology at Vanderbilt University Medical Center. Dr. Penson’s research is focused on health services research and clinical epidemiology as applied to urologic disease. His primary focus is on prostate cancer, where he has published extensively both on localized and advanced disease. He has obtained numerous grants from the National Cancer Institute, the Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute to study the comparative effectiveness of treatments for localized prostate cancer. He is the Principal Investigator (PI) of the Prostate Cancer Outcomes Study (PCOS), a large population-based study of prostate cancer survivors funded by the NCI that includes the longest longitudinal patient-reported follow-up in the field. Dr. Penson is also the PI of the CEASAR study, a comparative effectiveness study of surgery vs. radiation for localized prostate cancer, funded by the US Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI). Over 3600 men have been enrolled in the CEASAR study that will determine “what works, in which patients and in whose hands.” Dr. Penson’s work has been published in a variety of journals, including the New England Journal of Medicine, JAMA, Health Affairs and JNCI. He recently chaired the International Consortium for Health Outcomes Measurement advanced prostate cancer panel that developed the standard set of patient-reported outcome measures for use in advanced disease. Dr. Penson currently chairs the National Institutes of Health’s Health Services Outcomes and Delivery (HSOD) study section which reviews almost all health services research grant submitted to the NIH.


Dr. Penson is also very active in the field of health policy. In addition to serving as Chairman of the American Urological Association’s Public Policy Council, Dr. Penson has served on various committees in the National Quality Forum, the Ambulatory Quality Alliance, the AMA Physician Consortium for Quality Improvement and AHRQ’s National Advisory Council. Susan N. Perkins, PhD Dr. Susan Perkins is Deputy Chief of the Cancer Training Branch of the Center for Cancer Training at the National Cancer Institute. Dr. Perkins received her B.S. in biochemistry from North Carolina State University and her doctorate in physiology from the University of Virginia, with further training in neuroendocrinology during postdoctoral fellowships at Stanford University and the Johns Hopkins University. She was recruited to NCI in 1990, first as a Senior Staff Fellow and then as an Investigator in what is now the NCI Center for Cancer Research (CCR). Her research interests focused on the development of animal models to study cancer preventive strategies and interactions among nutritional factors, hormones, and genetic susceptibility to cancer. Subsequently, she was concurrently Associate Director of the NCI Cancer Prevention Fellowship Program and a member of the NCI CCR Laboratory of Biosystems and Cancer (2000-2006) and then a Research Assistant Professor in the Department of Nutritional Sciences at the University of Texas at Austin, before returning to NCI as a Program Director in the Cancer Training Branch in 2010. Consistent with her long-time interests in cancer prevention and in the training of the next generation of scientists, her grants portfolio comprises mentored career development awards and institutional training awards. Gina R. Petroni, PhD Dr. Petroni is Professor and Director of the Division of Translational Research and Applied Statistics in the Department of Public Health Sciences at the University of Virginia Health Systems, and Director of the Biostatistics Shared Resource for the UVa Cancer Center. She has considerable experience in the design, monitoring and analysis of clinical trials, and statistical experimental design. She is a member on several DSMBs, which include institutional based networks, national based networks (NHLBI) and the ASCO foundation. She has served on the UVA Health Sciences Institutional Review Board; the Cancer Center Data & Safety Monitoring, and Protocol Review Committees; and has been a reviewer for NCI & NIH either as a committee member or ad hoc, continuously for the last twenty years. Most recently, she was appointed to the NCI CIRB Adult Central IRB - Early Phase Emphasis. The proper design and analysis of clinical trials is her primary area of interest. As a mentor at UVa, she works with residents, fellows, new investigators, and new faculty on the proper design and analysis of clinical research. Specialty Preferences: early phase clinical trial design, melanoma & immunology clinical trial designs.


Tatiana M. Prowell, MD Dr. Prowell holds a hybrid government-academic appointment with FDA’s Office of Hematology & Oncology Products and the Johns Hopkins School of Medicine. At the FDA, she serves as Breast Cancer Scientific Liaison within the FDA’s Office of Hematology & Oncology Products, where she was the principal architect of FDA’s policy on accelerated approval using pathological complete response as a novel regulatory endpoint in the neoadjuvant high-risk breast cancer setting. At Johns Hopkins, she is an Assistant Professor in the Breast Cancer Program in the Kimmel Comprehensive Cancer Center and staffs the second opinion breast cancer clinic. Dr. Prowell received her BA degree from Bard College in Languages and Literature, and her MD degree from the Johns Hopkins School of Medicine with election to the Phi Beta Kappa and Alpha Omega Alpha honor societies. She subsequently completed her internal medicine residency and medical oncology fellowship at Johns Hopkins Hospital. She is a three-time recipient of FDA’s Excellence in Communication Award. She is an enthusiastic medical educator and mentor currently serving on the faculty of the ASCO/AACR Methods in Clinical Cancer Research Workshop, the Accelerating Anti-Cancer Agent Development and Validation Workshop, the Society for Translational Oncology Fellows’ Forum, and the Dana Farber Clinical Investigator Seminar Series, among several others. Mary W. Redman, PhD Dr. Mary Redman is an Associate Member of the Clinical Research Division of Fred Hutchinson Cancer Research Center in Seattle, Washington. She is the Lead Statistician of the Lung Cancer Committee Southwest Oncology Group and Lead Statistician of the Lung Map Trial. She received her PhD in Biostatistics from the University of Washington in 2004. Dr. Redman is interested in statistical methodology for the estimation of causal effects from observational and experimental data. In particular, she is interested in approaches to estimate the effects of time-varying treatments and/or exposures and complex systems. Dr. Redman is also a statistician with the Southwest Oncology Group statistical center. She is a statistician for Phase II, Phase III and ancillary studies for lung cancers in the Southwest Oncology Group and is also involved in prevention trials in the group. Specialty Preferences: Clinical research division biostatistics; clinical trial design; clinical trial design incorporating biomarkers; lung cancer


Meredith M. Regan, ScD Meredith M. Regan, Sc.D., is Associate Professor of Medicine, Department of Biostatistics & Computational Biology, Dana-Farber Cancer Institute and Harvard Medical School. Dr. Regan’s research focuses on clinical and translational research in breast and genitourinary cancers. She is Group Statistician for the International Breast Cancer Study Group, an international cooperative clinical trials group, and is a member of the NCI Breast Cancer Steering Committee and the Early Breast Cancer Trialists’ Collaborative Group steering committee. Dr. Regan also Co-Directs the Biostatistics & Computational Biology Cores for the Dana-Farber/Harvard Cancer Center Prostate Cancer SPORE and Breast Cancer SPORE. David Rimm, MD, PhD I am a board certified pathologist with sign-out experience and 22 years of experience running a research lab, largely focused on translational research using both fresh and formalin fixed tissue. My current research focuses on quantitative pathology using the AQUA® technology invented in my laboratory. The method allows quantitative analyses of proteins or RNAs expressed by tumors as assessed in tissue microarrays or conventional sections. Current efforts are related to using AQUA for prediction of response to therapy, invasion and metastasis and for biospecimen science. Specifically we are studying domain specific protein expression and prediction of response to therapy in both targeted and immune therapies. Outside Yale, I am a member of the TransALTTO committee and a member of the SWOG Breast Translational Science Committee. I am a member of the NCCN sponsored multi-institutional Pathologists Consortium to assess PD-L1 companion diagnostic testing and was a Co-Chair of the NCCN Tissue Allocation work group. I also serve on the Molecular Oncology committee for the College of American Pathologists (CAP). I was the scientific co-founder of HistoRx Inc (sold to Genoptix/Novartis in 2012), and Metamark Genetics Inc, a Cambridge-based prognostic determinant company. Virgil H. Simons, MPA Mr. Simons is a member of the American Association for Cancer Research, American Society of Clinical Oncology, European Association of Urology, American Public Health Association, and is the Chair Emeritus (FY2012) of the Congressionally Directed Medical Research Program for prostate cancer. He is a member of the External Advisory Board for Northwestern University Medical Center’s Prostate Cancer SPORE, the External Advisory Committee of the Center for Clinical Research at Clark Atlanta University, and the Advisory Board of CURE magazine. He is also a member of the external advisory panel for advocate development for the African Organization for Research and Training in Cancer. Mr. Simons has received several awards in recognition of his work on behalf of those affected by a diagnosis of prostate cancer including the Cancer Leadership Award from the American Association for Cancer


Research, the Catherine Logan Award for Service to Cancer Survivorship from the National Coalition for Cancer Survivorship, and the HOPE AWARD of the Intercultural Cancer Council. Prior to his involvement in healthcare, he had an extensive career in the textile, financial services, international trade and retail markets as a senior executive and/or entrepreneur. He has completed course work for an MBA, and recently received a MPA degree concurrent with the public health mission of The Prostate Net. George W. Sledge, Jr., MD Dr. George W. Sledge, Jr. is Professor of Medicine and Chief, Division of Oncology, at the Stanford University School of Medicine and co-director of the Stanford Cancer Institute’s Translational Oncology Program. Trained in Internal Medicine and Medical Oncology, he has devoted his professional career to understanding the biology and improving the treatment of breast cancer. He is active as both a laboratory and clinical researcher, with more than 300 scientific publications. He served as chair of the Eastern Cooperative Oncology Group’s Breast Cancer Committee (2003-2010), as a member of the Food and Drug Administration’s Oncology Drug Advisory Committee, and as a member of the Department of Defense’s Breast Cancer Research Program’s Integration Panel. He is Past President of the American Society of Clinical Oncology, and currently serves on the Scientific Advisory Boards for both the Komen for the Cure Foundation and the Triple Negative Breast Cancer Foundation. He is the recipient of numerous scientific awards, including the Breast Cancer Research Foundation’s Jill Rose Award, the Komen Foundation’s Brinker Award for Scientific Distinction, and the San Antonio Breast Cancer Symposium’s William L. McGuire Award. His research interests have focused on novel biologic approaches to breast cancer therapy. Franklin O. Smith, MD, FAAP, FACP Franklin O. Smith, III, M.D., Vice President for Medical Affairs at Medpace and Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine. Prior to joining Medpace in 2014, Dr. Smith served as the Clinical Director of the University of Cincinnati Cancer Institute at the University of Cincinnati, Director of the Division of Hematology/Oncology at Cincinnati Children’s Hospital Medical Center and Vice-Chair of the Children’s Oncology Group. Dr. Smith received his B.S. from Wofford College and his M.D. from the University Of South Carolina School Of Medicine. He was a resident in pediatrics at the University Of Florida College Of Medicine and did fellowship training in pediatric hematology/oncology at the University of Washington and the Fred Hutchinson Cancer Research Center. Dr. Smith has clinical expertise in hematopoietic stem cell transplantation and research interests in acute myeloid leukemia and Fanconi anemia. This is his sixth year to serve on the faculty at the ASCO/AACR Workshop. Specialty Preferences: Hematology/oncology; pediatric oncology; hematopoietic stem cell transplantation; acute myeloid leukemia; Fanconi anemia


Chris H. Takimoto, MD, PhD Chris H. Takimoto, MD, PhD grew up in southern California and graduated from Stanford University in 1979 with a B.S. degree in Chemistry. He received a Ph.D. in Pharmacology and an M.D. degree from Yale University in 1986. After finishing residency training in Internal Medicine at the University of California, San Francisco in 1989, he moved to Bethesda, Maryland to complete a fellowship in Medical Oncology at the National Cancer Institute in 1993 and a second fellowship in Clinical Pharmacology at the Uniformed Services University of the Health Sciences in 1996. From 1996 to 2000, he served as a Senior Investigator in the Developmental Therapeutics Department in the Medicine Branch at the National Cancer Institute and as an Assistant Professor of Medicine in the Division of Clinical Pharmacology at the Uniformed Services University. In 2000, he moved to the University of Texas Health Science Center at San Antonio (UTHSCSA) as an Associate Professor of Medicine in the Division of Medical Oncology. From 2004 to 2007, he held the position of Director of Pharmacology at the Institute for Drug Development (IDD) at the Cancer Therapy & Research Center (CTRC) in San Antonio, TX, where he was also the Zachry Chair for Translational Research. Dr. Takimoto was also an Adjunct Professor of Pharmacology at the UTHSCSA. In 2007, he became one of the founding members of the South Texas Accelerated Research Therapeutics (START) in San Antonio, an independent oncology clinical research center dedicated to oncology early development trials. In 2008, Dr. Takimoto moved to Johnson & Johnson, where he is currently Vice President and head of Translational Medicine Early Development in the Oncology Therapeutic Area at Janssen R&D, LLC, a member of the Janssen Pharmaceutical Companies of Johnsons & Johnson. Dr. Takimoto's research interests include the pharmacology of new anticancer agents, oncology drug development, pharmacokinetics and pharmacodynamics, Phase I clinical trials, and novel treatments for gastrointestinal malignancies. He has published over 160 research articles, reviews, editorials, and book chapters. He has served on the editorial board of the Journal of Clinical Oncology, Clinical Cancer Research, Cancer Chemotherapy and Pharmacology, Investigational New Drugs, and several other oncology publications. Andrea B. Troxel, ScD I am Professor and Associate Director of Biostatistics at the University of Pennsylvania, Director of Biostatistics at the Leonard Davis Institute Center for Health Incentives and Behavioral Economics, Director of the Biostatistics Shared Resource at the Abramson Comprehensive Cancer Center, Senior Scholar in the Center for Clinical Epidemiology and Biostatistics, and an elected Fellow of the American Statistical Association. I have experience with all phases of clinical studies in medicine, with a particular focus on behavioral health and oncology. My methodological research has focused on the areas of clinical trials, missing data, and longitudinal studies.


Daniel D. Von Hoff, MD, FACP Daniel D. Von Hoff, M.D., F.A.C.P. is currently Physician in Chief, Distinguished Professor Translational Research Division at TGen (Translational Genomics Research Institute) in Phoenix, Arizona. He is also Chief Scientific Officer for HonorHealth Clinical Research Institute and is the Medical Director of Research at McKesson Specialty Healthcare and the Scientific Medical Officer for US Oncology Research and leader of the Translation Oncology Program (TOP) specializing in phase I clinical trials done in the US Oncology Research network. He also holds an appointment as Professor of Medicine, Mayo Clinic, Scottsdale, AZ. Dr. Von Hoff’s major interest is in the development of new anticancer agents, both in the clinic and in the laboratory. He and his colleagues were involved in the beginning of the development of many of the agents we now use routinely, including: mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine, irinotecan, nelarabine, capecitabine, lapatinib, vismodegibm nab-paclitaxel, nal-IRI, and others. At present, he and his colleagues are concentrating on the development of molecularly targeted therapies particularly for patients with advanced pancreatic cancer. Dr. Von Hoff has published more than 675 papers, 140 book chapters and over 1170 abstracts. Dr. Von Hoff received the 2010 David A. Karnofsky Memorial Award from the American Society of Clinical Oncology for his outstanding contributions to cancer research leading to significant improvement in patient care. Dr. Von Hoff was appointed to President Bush’s National Cancer Advisory Board in 2004-2010. Dr. Von Hoff is the past President of the American Association for Cancer Research (the world’s largest cancer research organization), a Fellow of the American College of Physicians, and a member and past board member of the American Society of Clinical Oncology. He is a founder of ILEX™ Oncology, Inc. (acquired by Genzyme after Ilex had 2 agents, alemtuzumab and clofarabine approved by the FDA for patients with leukemia). Dr. Von Hoff is founder and the Editor Emeritus of Investigational New Drugs – The Journal of New Anticancer Agents; and, past Editor-in-Chief of Molecular Cancer Therapeutics. He is a co-founder of the AACR/ASCO Methods in Clinical Cancer Research Workshop. He is also proud to have been a mentor and teacher for multiple medical students, medical oncology fellows, graduate students, and post-doctoral fellows. Christopher G. Willett, MD Dr. Willett is Chairman of the Department of Radiation Oncology and a specialist in gastrointestinal cancers. He joined the Duke faculty in March, 2004. He formerly was Clinical Director of Radiation Oncology at Massachusetts General Hospital and Professor of Radiation Oncology at Harvard University School of Medicine. Dr. Willett received his Bachelor and M.D. degree from Tufts University in Boston. He completed a surgical internship at Vanderbilt University Medical Center and a residency in Radiation Medicine at Massachusetts General Hospital. He joined the faculty of Harvard in 1986 after completing his residency and fellowship. He also has held appointments as a radiation oncologist at the Brigham and Women's Hospital and Dana-Farber Cancer Center. Dr. Willett has served as the President of the International Society of Intraoperative


Radiation Therapy (ISIORT) and the International Society of Gastrointestinal Oncology (ISGIO). He also has served as Chair of the GI Committee of the Radiation Therapy Oncology Group. His research interests focus on the study of new therapies in the treatment of patients with gastrointestinal cancers. Terence Z. Wong, MD PhD Dr. Wong is Professor of Radiology and Chief of Nuclear Medicine and Director of Molecular and Translational Imaging at the University of North Carolina. His primary academic interest is oncologic imaging, in particular developing and applying functional/anatomic imaging strategies to guide patient management. Dr. Wong is one of the faculty Directors of the Translational Imaging Core at the Lineberger Comprehensive Cancer Center at UNC. He is a member of the ECOG-ACRIN group where he serves as the imaging chair for the GI and GU committees, and is a member of the NCI GI Steering Committee.

Documents

2015 ASCO/AACR Methods in Clinical Cancer Research Workshop